SEC-MALS: Multiple AAV CQAs

Size-exclusion chromatography combined with multi-angle light scattering (SEC-MALS) delivers high-precision AAV quantitation in a single 30-minute experiment. The following AAV quality attributes are measured simultaneously by SEC-MALS:

Empty/full ratio

Capsid titer (Cp) and genome titer (Vg)

Aggregate content

The same experiments can provide extended characterization of AAV vectors:

Capsid integrity

Capsid size (Rh or Rg) and distribution

Capsid and genome molar mass (Mw)

Impurities such as free DNA or host-cell proteins

Instrument control, data acquisition, analysis and reporting are all provided by ASTRA™ software with the Viral Vector Analysis module. We provide a platform SEC-MALS method, specifically built for AAV quantitation and is easily customizable for every product and serotype. With ASTRA’s 21 CFR Part 11-compliant option, SEC-MALS is readily positioned for supporting IND or BLA analytics packages, lot-to-lot comparisons and release assays of AAV-based gene therapy products.